Last updated: 03/05/2025 05:30:31
Efficacy and safety of niraparib in recurrent ovarian cancer
GSK study ID
214838
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Efficacy and safety of niraparib in recurrent ovarian cancer: A systematic literature review and network meta-analysis
Trial description: This network meta-analysis will be conducted to evaluate efficacy, safety, and impact on Health-related quality of life (HRQoL) of niraparib versus olaparib and rucaparib as maintenance treatment for participants with platinum-sensitive recurrent ovarian cancer with breast cancer gene (BRCA) or germline BRCA (gBRCA) mutant status.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Progression-free survival
Timeframe: Up to 5 weeks
Secondary outcomes:
Overall survival
Timeframe: Up to 5 weeks
Cross-over adjusted overall survival
Timeframe: Up to 5 weeks
Progression-free survival 2
Timeframe: Up to 5 weeks
Time-to-first subsequent therapy
Timeframe: Up to 5 weeks
Time-to-second subsequent therapy
Timeframe: Up to 5 weeks
Number of participants with any adverse event (AE), Grade 3/4 AE, Grade >=3 AE, Serious AE, AE causing death, AE of special interest, Discontinuation due to AE
Timeframe: Up to 5 weeks
Euro Quality of life- 5 Dimensional Visual analogue scale (EQ-5D VAS) scores over time
Timeframe: Up to 5 weeks
Functional Assessment of Cancer Therapy using Ovarian Symptom Index
Timeframe: Up to 5 weeks
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-27-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2021 to September 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Women aged 18 years or older undergoing treatment for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Participants should have experienced at least one recurrence of disease.
- Women younger than 18 years and/or undergoing treatment for cancer other than ovarian, fallopian tube, or primary peritoneal cancer.
- Participants who have not experienced disease recurrence (i.e., participants receiving first-line treatment).
Inclusion and exclusion criteria
Inclusion criteria:
- Women aged 18 years or older undergoing treatment for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Participants should have experienced at least one recurrence of disease.
- Participants should be platinum-sensitive and be in response (complete or partial) to chemotherapy with a platinum-based agent.
- Studies in which participants received niraparib, olaparib or rucaparib as maintenance therapy will be included.
- Studies with any drug therapy comparator or placebo comparator will be included.
- Studies reporting on efficacy, safety, and HRQoL outcomes will be included.
- Randomized controlled trials will be included.
- Studies with publication date from May 2017 to present for niraparib and olaparib. Database will be systematically searched since inception for rucaparib.
Exclusion criteria:
- Women younger than 18 years and/or undergoing treatment for cancer other than ovarian, fallopian tube, or primary peritoneal cancer.
- Participants who have not experienced disease recurrence (i.e., participants receiving first-line treatment).
- Studies reporting only outcomes for mutation-specific subgroups of wild-type non-BRCA mutation (non-BRCAm) participants.
- Participants with platinum-resistant/refractory disease.
- Studies in which participants received maintenance therapy with an intervention other than niraparib, olaparib or rucaparib will be excluded.
- Any study in which neither placebo nor other drug therapy is a comparator.
- Publications reporting on outcomes other than the efficacy, safety, and HRQoL outcomes.
- Study designs other than randomized controlled trials.
- Publications published before May 2017 will be excluded for niraparib or olaparib.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2021-27-09
Actual study completion date
2021-27-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website